The implantation of siG12D LODERs is selected to meet current gastroenterology endoscopic ultrasound (EUS) biopsy procedures, proved to be highly effective and safe.

Drug: Gemcitabine or FOLFIRINOX

Gemcitabine or FOLFIRINOX

Other Name: Chemotherapy

Detailed Description:

In this Phase II study a single dose 3,000µg (eight 375µg siG12DLODERs) will be administered to patients with unresectable LAPC combined with chemotherapy treatment (Gemcitabine or FOLFIRINOX). This will be the first study to assess the response rate of the siG12D LODER in patients with unresectable LAPC. The study is of a two-arm design with one arm receiving siG12D LODER + chemotherapy, while the other arm receiving ony chemotherapy.

The investigational agent siG12D LODER is a miniature biodegradable capsule that encompasses the drug, designed and produced by Silenseed Ltd. The implantation of LODERs is selected to meet current gastroenterology endoscopic ultrasound (EUS) biopsy procedures, proved to be highly effective and safe.

siG12D LODER has been studied in the escalating dose Phase I study of 12 patients, and results showed a high safety and tolerability profiles, with no single DLT.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Provide written informed consent and be between the ages of 18 and up.

Have an unresectable, locally advanced diagnosed adenocarcinoma of the pancreas. Or patients with a tumor who are not planning to undergo surgery due to a high surgical risk (e.g., coagulopathy or severe congestive heart failure).

Allocated to receive standard of care chemo as first line treatment in accordance with treating physician recommendation.

Have a target tumor that is accessible for intratumoral administration by PTA or EUS guidance as determined by the radiologist/gastroenterologist performing the PTA/EUS injection.

Have an ECOG performance status of ≤ 1

Have a life expectancy of ≥ 3 months.

If female and of child-bearing potential, have a negative serum pregnancy test during screening.

Agree to use a barrier method of contraception if sexually active (both men and women) from the time of administration of the first treatment and for at least 8 weeks after treatment.

Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months) or any other metastases

Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancers from which the subject has been disease-free for at least 5 years

Severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation <90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause systemic or regional hypoxemia

Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery

Treatment of pancreatic cancer with surgery or radiation therapy prior to study entry

Prior therapy with an hypoxic cytotoxin

Subjects who participated in an investigational drug or device study within 28 days prior to study entry

Known infection with HIV, hepatitis B virus, or hepatitis C virus

Females who are pregnant or breast-feeding

Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study

Unwillingness or inability to comply with the study protocol for any reason

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676259